Lead System Designer

Peer Consulting Resources Inc.

Job Location:

Waukesha, WI - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Contact Details:

Bisane
Email:
Cell:

Job Title: Lead System Designer

Location: Waukesha WI (onsite)

Duration: 12 Months

Years of Experience: 8 Yrs.

Required Hours/Week: 40hrs./Week

Duties and Responsibilities:

Develop the system architecture based on user needs functional requirements and design inputs.
Decompose high-level requirements into subsystem and component-level specifications.
Lead trade-off studies (performance cost reliability manufacturability).
Define interfaces (mechanical electrical software) and ensure system integration integrity.
Guide cross-functional teams (hardware firmware mechanical and software).
Conduct design reviews (PDR CDR TRR).
Mentor junior engineers and foster systems thinking across the team.
Own requirements management traceability from user needs to verification results.
Identify technical risks and lead mitigations throughout the lifecycle.
Ensure design complies with applicable standards and regulations (e.g. ISO 13485 IEC 60601 ISO 14971).
Define and oversee system verification plans and test strategies.
Support V&V activities and integration testing.
Ensure the design satisfies all intended use and regulatory requirements.
Interface with product management quality manufacturing and supply chain teams.
Support design transfer to manufacturing and post-market design changes.
Collaborate with suppliers for system-level components and integration.

What You Will Bring:

Good Knowledge of GE DHF on both Software and H/W development process is preferable.
System architecture & modeling (SysML Model-Based Systems Engineering preferred).

Skills Required:

Requirements management tools (e.g. IBM DOORS Jama Polarion).
Familiarity with embedded systems analog/digital design and mechanical integration.
Design for reliability manufacturability and serviceability.
FMEA FTA and risk-based design principles.
Strong technical leadership across diverse disciplines.
Excellent documentation and communication skills for cross-functional alignment.
Decision-making under uncertainty and trade-off evaluation.
Regulatory compliance alignment knowledge including ISO 13485 IEC 60601 ISO 14971 IEC 62304 (software) IEC 61010. Understanding of FDA design control requirements (21 CFR 820.30).

Contact Details: Bisane Email: Cell: Job Title: Lead System Designer Location: Waukesha WI (onsite) Duration: 12 Months Years of Experience: 8 Yrs. Required Hours/Week: 40hrs./Week Duties and Responsibilities: Develop the system architecture based on user needs functional req...